A Phase 2 Study of Mosliciguat in PH-ILD

• Research type

  Research Study

• Full title

  A Phase 2, Randomized, Placebo-Controlled Trial to Assess the Efficacy and Safety of Mosliciguat in Participants with Pulmonary Hypertension associated with Interstitial Lung Disease

• IRAS ID

  1010435

• Contact name

  Schlag Brian

• Contact email

  brian.schlag@pulmovant.com

• Sponsor organisation

  Pulmovant, Inc.

• Clinicaltrials.gov Identifier

  NCT06635850

• Research summary

  Pulmovant Inc. is conducting a study of an investigational medicine, called mosliciguat, for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD). The purpose is to find out if mosliciguat is safe and effective in treating adults who live with PH-ILD. Approximately 120 people (18 - 80 years old) with a diagnosis of PH-ILD will participate at around 85 sites globally. The study consists of: • Screening (up to 6 weeks) •Part 1 – Placebo-controlled treatment period (24 weeks): Participants will be assigned 2:1 to either mosliciguat or placebo. There will be monthly visits to the study site and weekly virtual visits during the first 2 months. •Part 2 – Extension period (28 weeks and up to about 200 weeks): After completion of Part 1, the participant will be able to continue with Part 2 of the study, also called the extension period. If the participant received mosliciguat during Part 1, they will continue to receive mosliciguat during Part 2. If they received placebo during Part 1, they will receive mosliciguat during Part 2. During the first 28 weeks, the participant will continue to have monthly visits to the study site and virtual visits. Thereafter, they will attend study site about every 3 months and complete virtual visits every 6 weeks.
  • Final Visit – Safety Follow-up: After the participant has stopped taking mosliciguat, they will have a follow-up visit 2 to 4 weeks after their last dose of mosliciguat, or their last scheduled study visit if they discontinue in Part 1. This final visit will take place whether they stop taking the medicine early, or if they complete the entire study. In total, participants will be in the study for about 4 and a half years. During the study they will be required to make clinic visits in person and they may be able to meet with study staff over the phone/video if applicable. At some of the clinic visits they will have blood drawn and have procedures to test their lungs and heart function

• REC name

  Wales REC 1

• REC reference

  24/WA/0298

• Date of REC Opinion

  13 Nov 2024

• REC opinion

  Further Information Favourable Opinion